Pertussis Infection Clinical Trial
Official title:
Seroepidemiological Study of Pertussis and Other Infectious Diseases
Serum samples will be corrected twice from the same youth subjects with one year interval.
Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from
an identical individual.
The relationship between the incidence and the demographic data or medical history of the
subjects will be discussed.
| Status | Recruiting |
| Enrollment | 4500 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Students of junior high school, high schools or college in Gifu prefecture - Students who can have the second blood drawing one year later - Students (and their parent when students are underage) whose written consent is obtainable. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gifu Prefecture Medical Association | Sanofi Pasteur S.A. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IgG | Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day). | 0 day, 365 day (2 points) | No |
| Secondary | Incidence of pertussis | Questionnaire | 0 day | No |
| Secondary | Antibodies of varicella, mumps and rubella | Questionnaire | 0 day | No |
| Secondary | Infection risk factors including family numbers, living space, with or without a cough patient in the surroundings, medical history and hospitalization | Questionnaire | 365 day | No |